The following data is part of a premarket notification filed by Wykle Research, Inc. with the FDA for Accu-mix Amalgamator.
| Device ID | K910632 |
| 510k Number | K910632 |
| Device Name: | ACCU-MIX AMALGAMATOR |
| Classification | Amalgamator, Dental, Ac-powered |
| Applicant | WYKLE RESEARCH, INC. 2222 HOT SPRINGS RD. Carson City, NV 89706 |
| Contact | Maurice M Weikel |
| Correspondent | Maurice M Weikel WYKLE RESEARCH, INC. 2222 HOT SPRINGS RD. Carson City, NV 89706 |
| Product Code | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-13 |
| Decision Date | 1991-03-15 |